meddevicedb.com FDA Device Reference

Review Panel

Clinical Chemistry FDA 510(k) Clearances & Devices

Cleared Devices
13,065
Product Codes (page)
61
Latest Decision
1987-08-21

Clearances · page 82 of 131

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K872447 CEDIA(TM) T UPTAKE Microgenics Corp. KHQ Class II 1987-08-21
K872219 GEN-PROBE (R) LUMINOMETER - LEADER (TM) Gen-Probe, Inc. JJQ Class I 1987-08-21
K872429 ISO-DATA 100 SERIES GAMMA COUNTER Iso-Data, Inc. JJJ Class I 1987-08-21
K870362 CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD Trace Scientific , Ltd. CIC Class II 1987-08-21
K872483 MODIFIED ALT (GPT) REAGENT Trace Scientific , Ltd. CKA Class I 1987-08-19
K870366 CREATININE REAGENT - PICRIC ACID METHOD Trace Scientific , Ltd. CGX Class II 1987-08-19
K870364 TOTAL BILIRUBIN REAGENT - DMSO METHOD Trace Scientific , Ltd. CIG Class II 1987-08-19
K870370 MAGNESIUM REAGENT - CALMAGITE METHOD Trace Scientific , Ltd. JGJ Class I 1987-08-19
K870369 CALCIUM REAGENT-METHYL THYMOL BLUE METHOD Trace Scientific , Ltd. CIA Class II 1987-08-19
K870365 DIRECT BILIRUBIN REAGENT - ACID DIAZO METHOD Trace Scientific , Ltd. CIG Class II 1987-08-19
K870371 TOTAL PROTEIN REAGENT - BIURET METHOD Trace Scientific , Ltd. CEK Class II 1987-08-19
K872484 MODIFIED ENZYMATIC BUN REAGENT Trace Scientific , Ltd. CDQ Class II 1987-08-19
K870372 ALBUMIN REAGENT - BROMCRESOL GREEN METHOD Trace Scientific , Ltd. CIX Class II 1987-08-19
K872324 LB 9502 - CLINILUMAT, LB 952 - AUTO-CLINILUMAT Berthold Analytical Instruments, Inc. JJQ Class I 1987-08-19
K870368 PHOSPHORUS REAGENT-DIRECT UV METHOD W/O REDUCTION Trace Scientific , Ltd. CEO Class I 1987-08-19
K871996 ABBOTT BIOTELL PREGNANCY TEST Abbott Laboratories LCX Class II 1987-08-18
K872306 SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA) Boehringer Mannheim Corp. CIC Class II 1987-08-18
K872912 TRIGLYCERIDE (UV) REAGENT Sigma Chemical Co. JGW Class I 1987-08-17
K872172 IMMUBEAD THYROID UPTAKE Immunotech Corp. KHQ Class II 1987-08-17
K872830 BIOTROL ALT/TGP MONOREACTIF Biotrol, USA, Inc. CKA Class I 1987-08-13
K872886 CARBON DIOXIDE Catachem, Inc. KMS Class II 1987-08-13
K871265 ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL E.I. Dupont DE Nemours & Co., Inc. LBS Class I 1987-08-13
K872192 IMMUBEAD T4 ENZYME IMMUNOASSAY KIT Immunotech Corp. KLI Class II 1987-08-13
K872813 EASY ST ANALYZER SYSTEM Em Diagnostic Systems, Inc. JJE Class I 1987-08-13
K872197 PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT Sigma Diagnostics, Inc. CIG Class II 1987-08-13
K872880 CALCITONIN RIA KIT Endocrine Associates, Inc. JKR Class II 1987-08-13
K872829 BIOTROL AST/TGO MONOREACTIF Biotrol, USA, Inc. CIT Class II 1987-08-13
K872191 IMMUBEAD T3 ENZYME IMMUNOASSAY KIT Immunotech Corp. CDP Class II 1987-08-13
K872049 NOVOCHECK/CHECKPOINT/CONTROL SOLUTION Garid, Inc. CGA Class II 1987-08-13
K872464 ION TRAP DETECTOR (ITD) The Perkin-Elmer Corp. DOP Class I 1987-08-11
K871332 CLEARPLAN Unipath , Ltd. CEP Class I 1987-08-05
K872727 LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE Serono Diagnostics, Inc. CEP Class I 1987-08-05
K871290 CENTRICELL(TM) Polysciences, Inc. JJH Class I 1987-08-05
K872728 BINAX IRMA TOTAL BETA-HCG TEST KIT Binax, Inc. JHI Class II 1987-08-05
K872023 AMYLASE TEST KIT Ciba Corning Diagnostics Corp. JFJ Class II 1987-08-05
K872376 LIPID CONTROL SERUM Biological Industries JJY Class I 1987-08-05
K872598 MICROMI-CK(TM) Intl. Immunoassay Laboratories, Inc. JHT Class II 1987-08-03
K872897 TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA. Serono Diagnostics, Inc. JLW Class II 1987-07-31
K872716 CIBA CORNING MODEL 580 ALLIANCE I.S.E. MODULE Ciba Corning Diagnostics Corp. JGS Class II 1987-07-31
K872309 MICROMEDIC COMBOSTAT LH/FSH KIT Micromedic Systems CGJ Class I 1987-07-31
K872592 IMACK-MB(TM) Intl. Immunoassay Laboratories, Inc. JHT Class II 1987-07-31
K872196 AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III American Dade JJS Class I 1987-07-31
K872320 EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616 Em Diagnostic Systems, Inc. JQB Class I 1987-07-27
K872322 EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95 Em Diagnostic Systems, Inc. JQB Class I 1987-07-27
K864544 DIABETES RISK DETECTOR Pearce Clinical Laboratories, Inc. JIL Class II 1987-07-27
K871726 OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY) Monoclonal Antibodies, Inc. CEP Class I 1987-07-27
K872263 TOTAL BILIRUBIN STANDARD CALIBRATOR Wako Chemicals USA, Inc. JIT Class II 1987-07-22
K872627 FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH Serono Diagnostics, Inc. CGJ Class I 1987-07-21
K872286 CIBA CORNING MAGIC LITE FT4 IMMUNOASSAY Ciba Corning Diagnostics Corp. CDX Class II 1987-07-21
K872511 CHLORIDE FOR CONTINUOUS FLOW INSTRUMENTS Catachem, Inc. CHJ Class II 1987-07-21
K871593 TDXR FETAL LUNG MATURITY Abbott Laboratories JHG Class II 1987-07-20
K872130 ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES Syva Co. JHI Class II 1987-07-16
K871853 V-MARC 88A COMPUTER V.Marc, A Div. of Pictorial, Inc. JQP Class I 1987-07-16
K872363 DYNATECH SPD 3000, #002-900-0000 Dynatech Laboratories, Inc. JQW Class I 1987-07-16
K872575 HDL CHOLESTEROL REAGENT Sigma Chemical Co. CHH Class I 1987-07-16
K872582 HIGH PRESSURE LIQUID CHROMATOGRAPHY SYSTEM Millipore Corp. LDM Class I 1987-07-16
K872295 CHOLESTEROL REAGENT Sigma Diagnostics, Inc. CHH Class I 1987-07-16
K871700 HCG MAB SOLID PHASE COMPONENT SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic JHI Class II 1987-07-15
K865083 AFFINITY(TM) I UPTAKE IMMUNIT(TM) Bd Becton Dickinson Vacutainer Systems Preanalytic KHQ Class II 1987-07-09
K872311 ABBOTT A-GENT LIQUID MAGNESIUM REAGENT Abbott Laboratories JGJ Class I 1987-07-09
K871977 DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR American Dade JJY Class I 1987-07-09
K872494 HITACHI 717 CHEMISTRY ANALYZER Boehringer Mannheim Corp. JJE Class I 1987-07-09
K872030 UNI-FAST LACTATE DEHYDROGENASE (LDH-L) Sclavo, Inc. CFJ Class II 1987-07-07
K872050 PARAMAX CHOLESTEROL REAGENT American Dade LBS Class I 1987-07-07
K872303 UNASSAYED CONTROL SERUM, ABNORMAL (BOVINE) Vanguard Diagnostic Systems JJY Class I 1987-07-07
K872304 UNASSAYED CONTROL SERUM, NORMAL (BOVINE) Vanguard Diagnostic Systems JJY Class I 1987-07-07
K872227 LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II Bio-Rad JJY Class I 1987-07-06
K872110 EASY-TEST AMMONIA (AMON) ITEM NO. 16695 Em Diagnostic Systems, Inc. JIF Class I 1987-07-01
K871550 PFI-20 POLARIZING FLUORIMETER The Perkin-Elmer Corp. KHO Class I 1987-07-01
K872305 IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX Diagnostic Products Corp. JLW Class II 1987-07-01
K870214 MODIFIED SALTEX REAGENT STRIPS Miles Laboratories, Inc. CHK Class II 1987-06-29
K872190 NOVA 13 SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER Nova Biomedical Corp. JGS Class II 1987-06-24
K872105 KODAK EKTACHEM 700XR ANALYZER Eastman Kodak Company JJE Class I 1987-06-23
K870969 CORTISOL-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT Canadian Bioclinical, Ltd. CGR Class II 1987-06-22
K870968 TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT Canadian Bioclinical, Ltd. CDP Class II 1987-06-22
K871547 ULTRA-VIOLET BUN REAGENT KIT (RATE) Biochemical Trade, Inc. CDQ Class II 1987-06-22
K871543 ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU. Catachem, Inc. CJE Class II 1987-06-22
K872063 TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II Hybritech, Inc. JHY Class II 1987-06-19
K872122 8000 SERIES GAS CHROMATOGRAPHS The Perkin-Elmer Corp. KZQ Class I 1987-06-17
K872103 KODAK EKTACHEM 700S ANALYZER Eastman Kodak Company JJE Class I 1987-06-17
K872177 TIPSEP-CORTISOL RIA DIAGNOSTIC KIT Nuclear Diagnostics, Inc. CGR Class II 1987-06-17
K872029 UNI-FAST CREATINE KINASE TEST (CK) Sclavo, Inc. JHS Class II 1987-06-17
K871892 TECHNICON RA(R) SYSTEMS & ASSIST(R) CLIN. ANALYZER Technicon Instruments Corp. KNK Class I 1987-06-17
K872104 KODAK EKTACHEM 700P ANALYZER Eastman Kodak Company JJE Class I 1987-06-17
K871303 DELFIA(TM) THYROXINE (T4) KIT Lkb Instruments, Inc. CDX Class II 1987-06-17
K872108 ABBOTT SPECTRUM BICARBONATE REAGENT KIT Abbott Laboratories KHS Class II 1987-06-17
K872079 RAICHEM(TM) SPIA(TM) APO A-1 REAGENTS Reagents Applications, Inc. MSJ Class I 1987-06-15
K871152 SIGMA'S CALCIUM PROCEDURE NO. 587 Sigma Diagnostics, Inc. CIC Class II 1987-06-12
K871973 IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. Instrumentation Laboratory CO JJG Class I 1987-06-11
K871308 ALLELIX PREGNANCY DETECTION KIT 48 TEST KIT Allelix, Inc. JHI Class II 1987-06-11
K871602 MICROCHECK LH OVULATION TEST Syntron Bioresearch, Inc. CEP Class I 1987-06-11
K871979 GAMMA GLUTAMYLTRANSFERASE REAGENT Intersect Systems, Inc. JPZ Class I 1987-06-11
K872010 MULTICHEM LDH-L REAGENT Simmler, Inc. CFJ Class II 1987-06-11
K870405 DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400) Diagnostic Systems Laboratories, Inc. CHP Class I 1987-06-08
K871975 MULTICHEM TOTAL PROTEIN REAGENT #S0928 Simmler, Inc. CEK Class II 1987-06-05
K871976 MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919 Simmler, Inc. CFR Class II 1987-06-05
K871780 ULTRAVIOLET ASPARTATE AMINO-TRANS (UV-AST/UV-GOT) Biochemical Trade, Inc. CIT Class II 1987-06-04
K871943 D.A.T. (TM) AMYLASE REAGENT Behring Diagnostics, Inc. CIJ Class II 1987-06-03
K871235 TANDEM(R) ICON(R) QSR(TM) HCG IMMUNO. ASSAY KIT Hybritech, Inc. JHI Class II 1987-06-03
K871902 THE URIC ACID REAGENT SET Macomb Biotechnology, Inc. KNK Class I 1987-06-03

13,065 clearances in the Clinical Chemistry panel. Data: openFDA.